JPRN-jRCTs031200140已完成1 期
Bioequivalence study of Aspirin Minitablets and Aspirin Powder in Healthy Adult Volunteers
Hida Noriko0 个研究点目标入组 6 人开始时间: 2020年10月8日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
Healthy Japanese adult males took the standard aspirin spray for the first period, followed by a 6-day rest period, and then aspirin mini tablets for the second period. Both formulations contained 100 mg of aspirin. There was no difference in the pharmacokinetic parameters of salicylic acid and aspirin in plasma, and there was no difference in the pharmacokinetics of aspirin depending on its form.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 45age old（—）
- 性别
- Male
入选标准
- •1) Age: those who were between 20 and 45 years of age at the time of obtaining consent.
- •2) Gender: male
- •3) Have the capacity to consent and adhere to the compliance requirements during participation in the research, undergo the pre-inspection specified in this research protocol, and Those who can report subjective symptoms, etc.
- •4) The physician in charge of the study has determined that participation in the study is not allowed by the physician in charge of the study in the preliminary examination prescribed in the study protocol. Those judged to be eligible.
排除标准
- •1) Subjects with a history (e.g., drug abuse/dependence, alcohol abuse/dependence, cardiac, hepatic, renal, pulmonary, eye, or blood disorders) that may affect the evaluation and safety of this study.
- •2) Subjects with a history of peptic ulcers or current illness
- •3) Subjects with a tendency to bleed
- •4) Subjects with aspirin asthma
- •5) Subjects taking medications (including supplements and dietary supplements) that may affect the evaluation and safety of this study
- •6) Subjects with a history of drug allergy
- •7) Those who regularly use excessive alcohol (those who cannot maintain abstinence from alcohol during the study period)
- •8) Subjects who have participated in other clinical research within 3 months of their participation in the study.
- •9) Any other person who is judged by the physician in charge of the study to be ineligible to be the subject of this study.
研究者
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